Posted by rob on March 28, 2005 under Uncategorized | 
NEW HAVEN, Conn., March 28 /PRNewswire-FirstCall/ — VION PHARMACEUTICALS,
INC. (Nasdaq: VION) announced today that it commenced dosing the first patient
on the Phase III pivotal trial of its anticancer agent CLORETAZINE(TM)
(VNP40101M) in relapsed acute myelogenous leukemia (AML).
Susan O’Brien, MD, Professor of Medicine in the Department of Leukemia,
and principal investigator for the trial at MD Anderson Cancer Center
commented, “The therapeutic options for patients with relapsed acute
myelogenous leukemia are limited and unsatisfactory. Given emerging evidence
of CLORETAZINE(TM) (VNP40101M)’s anti-leukemia activity, MD Anderson is
pleased to be the lead institution for this global Phase III clinical trial.”
“Encouraging CLORETAZINE(TM) (VNP40101M) results in early phase trials
have also provided important leads in other malignancies,” said Frank Giles,
MD, Chief, Section Developmental Therapeutics, Department of Leukemia,
University of Texas, MD Anderson Cancer Center. “The launch of a pivotal
Phase III trial is an important milestone in the development of any drug; it
is especially gratifying to see an AML investigational agent go to Phase III
so rapidly” said Giles.
Alan Kessman, Chief Executive Officer, stated “We are proud of our
continued progress in the development program for CLORETAZINE(TM) (VNP40101M).
We consider the start of this pivotal trial as a major milestone
accomplishment for Vion. We are hopeful that the Phase III trial will prove
CLORETAZINE(TM) (VNP40101M)’s potential to bring a new treatment to patients
in first relapse AML, which is currently an unmet medical need.”
Vion recently reached agreement with the U.S. Food and Drug Administration
(FDA) on a Special Protocol Assessment (SPA) for this trial. The trial is a
double-blind, placebo-controlled randomized evaluation of an experimental
treatment consisting of Ara-C plus CLORETAZINE(TM) (VNP40101M) versus a
control arm regimen of Ara-C and placebo. This trial is designed to accrue
patients in first relapse whose first complete remission (CR) was more than
three months but less than twenty-four months in duration. Patients will be
stratified according to: (i) age, greater than or less than 60 years and (ii)
length of the first CR, more than or less than 12 months in duration.
The primary endpoint for the trial is the objective response rate, defined
as CR plus CRp (a complete remission with incomplete recovery of the platelet
count). Secondary endpoints include time to progression, duration of response,
overall survival and toxicity. An interim analysis is planned.
Vion Pharmaceuticals, Inc. is developing novel agents for the treatment of
cancer. Vion has two agents in clinical trials: CLORETAZINE(TM) (VNP40101M),
a unique sulfonylhydrazine alkylating agent, and Triapine(R), a potent
inhibitor of a key step in DNA synthesis. In preclinical studies, Vion is
also evaluating KS119, a hypoxia-selective compound from the sulfonylhydrazine
class, and heterocyclic hydrazones. For additional information on Vion and
its product development programs, visit the Company’s Internet web site at
http://www.vionpharm.com .
This news release contains forward-looking statements. Such statements are
subject to certain risk factors which may cause Vion’s plans to differ or
results to vary from those expected, including Vion’s ability to secure
external sources of funding to continue its operations, the inability to
access capital and funding on favorable terms, continued operating losses and
the inability to continue operations as a result, its dependence on regulatory
approval for its products, delayed or unfavorable results of drug trials, the
possibility that favorable results of earlier clinical trials are not
predictive of safety and efficacy results in later clinical trials, the need
for additional research and testing, and a variety of other risks set forth
from time to time in Vion’s filings with the Securities and Exchange
Commission, including but not limited to the risks discussed in Vion’s Annual
Report on Form 10-K for the year ended December 31, 2004. Except in special
circumstances in which a duty to update arises under law when prior disclosure
becomes materially misleading in light of subsequent events, Vion does not
intend to update any of these forward-looking statements to reflect events or
circumstances after the date hereof or to reflect the occurrence of
unanticipated events.
COMPANY CONTACT: Vion Pharmaceuticals, Inc.
Alan Kessman, Chief Executive Officer
Howard B. Johnson, President
(203) 498-4210 phone
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=109&STORY=/www/story/03-28-2005/0003285507&EDATE=
Posted by rob on under Uncategorized |
Gene project would seek keys to cancer
March 28, 2005
Federal officials are planning to compile a comprehensive catalog of the genetic abnormalities that characterize cancer, in hopes of discovering important new clues about how to diagnose, prevent, and treat cancer, according to a report in today’s issues of The New York Times.
The proposed Human Cancer Genome Project would be greater in scale than the Human Genome Project, which has already mapped the blueprint of the human genetic structure. Its goal woudl be to determine the DNA sequence of thousands of tumor samples, the Times reported, Researchers would look for mutations that give rise to cancer or sustain it.
The project’s proponents say a data bank of mutations would be freely available to researchers.
”Knowing the defects of the cancer cell points you to the Achilles’ heel of tumors,” Dr. Eric S. Lander, director of the Broad Institute, a research center in Cambridge, told the newspaper.
The project is projected to cost about $1.35 billion over nine years; funding sources are currently uncertain. The government would probably start with smaller pilot projects, officials said.
The proposal was presented last month to an advisory committee to the National Cancer Institute. It was drawn up by a group led by Lander and Dr. Leland H. Hartwell, a Nobel laureate who is president of the Fred Hutchinson Cancer Research Center in Seattle.
They and others say the time is right for such a project because the Human Genome Project has provided the human DNA sequence, with which tumor cells could be compared. In addition, the cost of such research is dropping. And discoveries of individual cancer-related genes have already helped lead to new drugs.
Boston.com / Business / Technology / Gene project would seek keys to cancer
Posted by rob on under Uncategorized |
March 28, 2005
Jen Christensen
Leukemia
Leukemia is a cancer of the bone marrow and blood that leads to an uncontrolled accumulation of blood cells. The disease can be classified as acute or chronic. Acute leukemia progresses very rapidly. It causes the formation of blood cells that aren’t fully developed, and thus, are unable to perform their natural function. Chronic leukemia progresses more slowly. This slower rate allows a greater number of normal cells to develop. Acute and chronic leukemia can be further divided into acute and chronic myelogenous leukemia and acute and chronic lymphocytic leukemia.
According to the Leukemia and Lymphoma Society, about 33,440 new cases of leukemia will be diagnosed in the U.S. this year. Acute lymphocytic leukemia accounts for about 3,830 cases of leukemia every year. It is the most common form of leukemia in children. Incidence is nine times higher in children one to four than in those 20 to 24. The other types of leukemia are most commonly diagnosed in late adulthood. About 11,920 cases of acute myelogenous leukemia are diagnosed annually. Annual incidence of chronic lymphocytic leukemia is about 8,190 cases and for chronic myelogenous leukemia, about 4,600 cases.
Lymphoma
Lymphoma is a type of cancer that develops in the lymphatic system. There are two main types: Hodgkin Lymphoma and Non-Hodgkin Lymphoma. The diseases are caused by an acquired genetic mutation causing excessive and uncontrolled growth of lymphocytes (specialized white blood cells).
About 62,250 cases of lymphoma will be diagnosed this year in the U.S. Roughly 7,880 cases are of Hodgkin lymphoma. It’s slightly more common in males than in females. Non-Hodgkin lymphoma is slightly more common than Hodgkin lymphoma. About 54,370 cases will diagnosed this year. As with Hodgkin lymphoma, males are affected slightly more often than females.
Leukemia and Lymphoma: Testing and Follow-up
To confirm a diagnosis of leukemia and lymphoma, doctors need to take a sample of bone marrow, the soft, spongy tissue inside larger bones. Testing is also done periodically after diagnosis to follow the effects of treatment and potential progression of the disease.
The most common site for bone marrow testing is the hipbone (posterior iliac crest). The skin in the area is cleaned and the patient is given a local anesthetic. Once the area is anesthetized, a small incision is made into the skin. A sharp, hollow needle is inserted through the incision, then into the bone. One of two types of tests may be performed. A bone marrow aspirate uses a syringe to withdraw a small amount of liquid within the bone marrow. This test is used to determine what types and how many blood cells are present in the bone marrow. The second test is a bone marrow biopsy. A slightly larger needle is inserted through the same space. The needle is rotated to cut and obtain a small specimen of bone. The needle is withdrawn and the bone sample is removed for analysis. A bone marrow biopsy can be used to look at the structure of the bone marrow.
After bone marrow aspiration and biopsy, a bandage is placed over the site to control bleeding. Patients may experience some degree of pain and discomfort after the procedure. There is also a risk of persistent bleeding and infection.
A Bone Marrow Blood Test
Patients with leukemia and lymphoma may require frequent bone marrow testing. Despite its necessity, many patients dislike the procedure because they may experience significant discomfort or pain.
But the days of frequent bone marrow testing may soon be over. Researchers at the University of Texas M.D. Anderson Cancer Center have developed a blood test that may provide much of the information obtained from the traditional bone marrow test. The blood test looks for molecular signs of the cancer within the blood. Researchers will look for the presence of certain proteins expressed on the surface of tumor cells, namely CD20, CD33 and CD52. In addition, the test will screen blood plasma for evidence of RNA and DNA that are specifically linked to leukemia and lymphoma.
The new blood test may not entirely replace the need for bone marrow testing. Researchers are hopeful it will greatly reduce the need for patients to undergo the painful traditional method of testing. The blood test has been licensed to Quest Diagnostics, Inc. Researchers hope it could be available by the end of the year.
AUDIENCE INQUIRY
For information about the test:
Quest Diagostics® – http://phx.corporate-ir.net/phoenix.zhtml?c=82068&p=irol-newsArticle&ID=665642&highlight=
For information on leukemia and lymphoma:
The Leukemia and Lymphoma Society, http://www.leukemia-lymphoma.org
WHOI – Healthbeat: Bone Marrow Blood Test
Posted by rob on under Uncategorized |
Thirty-four-year-old Melissa Curley is relying on the kindness of strangers in her battle against leukemia. Chemotherapy hasn’t helped the Northern Cheyenne woman defeat the life-threatening chronic myelogenous leukemia that doctors diagnosed nearly three years ago. So her hope now rests in a bone marrow transplant to restore her to health.
Posted by rob on under Uncategorized |
In Jerry’s diary for Sunday he mentions some of the things Dr. Talpaz said this week
about the tremendous progress that is being made in the treatment of CML. For those
of you who may be newly diagnosed and not aware of all of the new drugs in the pipeline
it will be inspirational to read.
Rob
3/27/2005 Sunday…Day 501:
“Dr. Talpaz says that with available treatments there will be very few patients who die from CML. He says that we have changed CML from a terminal disease with a life expectancy of only a few years to a truly chronic disease with a median survival approaching 25 years.”
“Dr. Talpaz speaks of many new CML drugs in the pipeline. In fact he has been asked to trial so many drugs that he can not possibly do trials on them all even though many look very good. By the way, he said that he and his research associates have developed a drug for the resistant T315I mutation and they are trying to bring it to trial. This makes about 5 new T315I drugs that I have heard about.”
http://www.newcmldrug.com/diary_interface/Results/Diary.asp
Posted by rob on under Uncategorized |
A hummingbird flies in a garden of Mexico City.
Posted by rob on under Uncategorized |
A hummingbird flies in a garden of Mexico City.
